DEN230041
- 510(k) number
- DEN230041
- Device name
- Sleep Apnea Feature
- Applicant
- Samsung Electronics Co., Ltd. KR
- Product code
- QZW — Over-The-Counter Device To Assess Risk Of Sleep Apne
- Decision date
- 2024-02-06
- Date received
- 2023-05-31
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Anesthesiology
Official FDA record: DEN230041
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.